(12)
`
`United States Patent
`Scribner et al.
`
`US006623505B2
`(10) Patent N0.:
`US 6,623,505 B2
`(45) Date of Patent:
`*Sep. 23, 2003
`
`(54) EXPANDABLE STRUCTURES FOR
`DEPLOYMENT IN INTERIOR BODY
`REGIONS
`(75) Inventors: Robert M. Scribner, Los Altos, CA
`(Us); Michael L_ R90, Redwood City,
`C A (Us)
`
`(73) Assigneez Kyphon Inc” Sunnyvale, CAWS)
`
`*
`
`Notice:
`
`This atent issued on a continued ros
`P
`P
`ecution application ?led under 37 CFR
`1.53(d), and is subject to the tWenty year
`
`patent term provisions of 35 USC 154(a)(2).
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`USC 154(b) by 0 days.
`
`_
`(21) Appl. No.. 09/918,942
`22 F1 d:
`l. 31 2001
`(
`)
`1 6
`J“
`’
`(65)
`Prior Publication Data
`Us 2002/0013600 A1 Jan‘ 31’ 2002
`.
`.
`Related U'S'Apphcatmn Data
`(62) Division of application No 09/404,662’ ?led on Sep 23’
`1999, now Pat. No. 6,280,456, which is a division of
`application No. 08/911,827, ?led On Aug- 15, 1997, HOW Pat-
`NO‘ 597L015‘
`(51) Int C]_7 ____ __
`
`A61M 29/00
`
`(56)
`
`(52) US. Cl. . . . . . . . . . . . . . . . .
`. . . . . . . . . . .. 606/192
`(58) Field of Search ............................... .. 606/192 193
`606/195 60 94 190 200. 604/20 960141)“);
`’
`’
`’
`’
`’
`’
`References Cited
`US. PATENT DOCUMENTS
`5,090,957 A
`2/1992 Mouta?s et 81.
`5,108,404 A
`4/1992 Scholten et 81.
`5,116,305 A
`5/1992 Milder et 81.
`5,176,692 A
`1/1993 Wilk et a1.
`
`//0
`
`5,263,931 A 11/1993 Miller
`5,275,622 A
`1/ 1994 LaZarllS et 91
`5,331,975 A
`7/1994 Bonnuti
`5,749,888 A
`5/1998 Yock
`5,766,151 A
`6/1998 Valley 91 a1~
`5,769,816 A * 6/1998 Barbut et a1. ............. .. 606/200
`5,788,703 A
`8/1998 Mittelmeier et 81.
`5,827,289 A 10/1998 Reiley et a1.
`5,928,260 A * 7/1999 Chin et a1. ................ .. 606/200
`6,132,824 A 10/2000 Hamlin
`
`FOREIGN PATENT DOCUMENTS
`
`* Cited by examiner
`
`_
`_
`_
`Primary Exammer—Kevm T. Truong
`(74) Attorney, Agent, or Firm—Ryan KromholZ & Manion,
`SC.
`ABSTRACT
`(57)
`Devices intended for deployment into interior body regions
`employ a catheter tube, Which carries an expandable struc
`ture. The catheter tube extends along a ?rst axis, While the
`expanded geometry of the structure is oriented about a
`second axis, WhlCh is not aligned With the ?rst axis. The
`asymmetry between the two axes Permlts deployment of the
`expandable structure in a symmetric fashion With respect to
`the natural axis of a targeted interior body region, even When
`the targeted interior body region is either asymmetric in
`
`geometry or Otherwise requires access along a path that is
`not aligned With the natural axis‘ The Structure can include
`spaced apart end regions, Which provide a non-conical
`diameter transition betWeen the diameter of the catheter tube
`and the larger diameter of the expanded structure. The
`non-conical diameter transition mitigates the tradeoff,
`present in conventional structures, betWeen achieving a
`desired maximum expanded diameter Without undesired
`reduction in the effective length of the structure.
`
`12 Claims, 13 Drawing Sheets
`
`//4
`
`M4
`
`//4
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`STRYKER EXHIBIT 1001, pg. 1
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`Sep. 23, 2003
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`Sheet 1 0f 13
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`Sep. 23, 2003
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`Sheet 7 0f 13
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`US 6,623,505 B2
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`200
`£50 270 X40 0240 /
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`\
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`V270
`z/o
`4?’? 1.44
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`1/0
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`4751.143
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`Sep. 23, 2003
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`ITFIIJIIIII IIIIIIIIJJ
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`@226
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`lJ/J III/l l/IJJ/j/JJII
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`US 6,623,505 B2
`
`1
`EXPANDABLE STRUCTURES FOR
`DEPLOYMENT IN INTERIOR BODY
`REGIONS
`RELATED APPLICATION
`This application is a divisional of application Ser. No.
`09/404,662 ?led Sep. 23, 1999 now US. Pat. No. 6,280,456
`Which is a divisional of application Ser. No. 08/911,827 ?led
`Aug. 15, 1997, now US. Pat. No. 5,972,015.
`FIELD OF THE INVENTION
`The invention relates to expandable structures, Which, in
`use, are deployed in interior body regions of humans and
`other animals.
`BACKGROUND OF THE INVENTION
`The deployment of expandable structures into interior
`body regions is Well knoWn. For example, expandable
`structures, generically called “balloons,” are deployed dur
`ing angioplasty to open occluded blood vessels. As another
`example, US. Pat. Nos. 4,969,888 and 5,108,404 disclose
`apparatus and methods the use of expandable structures for
`the ?xation of fractures or other osteoporotic and non
`osteoporotic conditions of human and animal bones.
`Many interior regions of the body, such as the vasculature
`and interior bone, possess complex, asymmetric geometries.
`Even if an interior body region is someWhat more
`symmetric, it may still be difficult to gain access along the
`natural axis of symmetry.
`For example, deployment of an expandable structure in
`the region of branched arteries or veins can place the axis of
`an expandable structure off-alignment With the axis of the
`blood vessel Which the structure is intended to occupy. As
`another example, insertion of an expandable structure into
`bone can require forming an access portal that is not aligned
`With the natural symmetry of the bone. In these instances,
`expansion of the structure is not symmetric With respect to
`the natural axis of the region targeted for treatment. As a
`result, expansion of the body is not symmetric With respect
`to the natural axis of the targeted region.
`It can also be important to maximiZe the siZe and surface
`area of an expandable structure When deployed in an interior
`body region. Current medical balloons manufactured by
`molding techniques are designed to be guided into a narroW
`channel, such as a blood vessel or the fallopian tube, Where
`they are then in?ated. In this environment, the diameter of
`the balloon is critical to its success, but the length is less so.
`Such balloons only need to be long enough to cross the area
`of intended use, With feW constraints past the effective
`portion of the in?ated balloon. This alloWs conventional
`balloons to be constructed in three molded pieces, compris
`ing a cylindrical middle section and tWo conical ends,
`bonded to a catheter shaft. As a practical matter, neither the
`length of the conical end, nor the length of the bond of the
`balloon to the catheter shaft, affect the function of conven
`tional balloons, and these regions on conventional balloons
`are often 1 cm in length or more. Indeed, the larger the
`balloon diameter, the longer the end cone, Which creates a
`tradeoff betWeen maximum effective length and maximum
`effective diameter. This tradeoff makes optimiZation of
`conventional structures problematic in interior structures
`With de?ned lengths, such as bone.
`SUMMARY OF THE INVENTION
`One aspect of the invention provides a device for deploy
`ment into bone. The device comprises an outer catheter tube
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`55
`
`60
`
`65
`
`2
`having a distal end. An inner catheter tube extends at least
`in part Within the outer catheter tube and has a distal end
`region that extends at least in part beyond the distal end of
`the outer catheter tube. An expandable structure has a
`proximal end secured to the outer catheter tube and a distal
`end secured to the inner catheter tube. The expandable
`structure extends outside and beyond the outer catheter tube
`and at least partially encloses the inner catheter tube.
`In a preferred embodiment, the expandable structure is
`siZed and con?gured for passage Within a cannula into bone
`When the expandable structure is in a collapsed condition.
`In another aspect of the invention, the outer catheter tube
`has an axis and expansion of the expandable structure is
`asymmetric about the axis.
`In another aspect of the invention, the expandable struc
`ture is adapted and con?gured to compress cancellous bone
`upon expansion of the expandable structure in bone.
`In another aspect of the invention, the inner catheter tube
`is moveable in relation to the outer catheter tube.
`Yet another aspect of the invention provides a system for
`treating bone that comprises the device and a cannula.
`Features and advantages of the inventions are set forth in
`the folloWing Description and DraWings, as Well as in the
`appended claims.
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a lateral vieW, partially broken aWay and in
`section, of a lumbar vertebra taken generally along line 1—1
`in FIG. 2;
`FIG. 2 is a coronal vieW of the lumbar vertebra, partially
`cut aWay and in section, shoWn in FIG. 1;
`FIG. 3 is a top vieW of a probe including a catheter tube
`carrying a tubular expandable structure of conventional
`construction, shoWn in a substantially collapsed condition;
`FIG. 4 is an enlarged side vieW of the tubular expandable
`structure carried by the probe shoWn in FIG. 3, shoWn in a
`substantially expanded condition;
`FIG. 5 is a lateral vieW of the lumbar vertebra shoWn in
`FIGS. 1 and 2, partially cut aWay and in section, With the
`expandable structure shoWn in FIGS. 3 and 4 deployed by
`transpedicular access When in a substantially collapsed
`condition;
`FIG. 6 is a coronal vieW of the transpedicular access
`shoWn in FIG. 5, partially cut aWay and in section;
`FIG. 7 is a lateral vieW of the transpedicular access shoWn
`in FIG. 5, With the expandable structure shoWn in FIGS. 3
`and 4 in a substantially expanded condition, forming a cavity
`that is not centered With respect to the middle region of the
`vertebral body;
`FIG. 8 is a coronal vieW of the transpedicular access
`shoWn in FIG. 7, partially cut aWay and in section;
`FIG. 9 is a coronal vieW of the lumbar vertebra shoWn in
`FIGS. 1 and 2, partially cut aWay and in section, With the
`expandable structure shoWn in FIGS. 3 and 4 deployed by
`postero-lateral access When in a substantially collapsed
`condition;
`FIG. 10 is a coronal vieW of the postero-lateral access
`shoWn in FIG. 9, With the expandable structure shoWn in a
`substantially expanded condition, forming a cavity that is
`not centered With respect to the middle region of the
`vertebral body;
`FIGS. 11A and 11B are side vieWs of improved expand
`able structures, each having an axis of expansion that is
`offset by an acute angle and not aligned With the axis of the
`supporting catheter tube;
`
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`3
`FIG. 12 is a lateral vieW of the lumbar vertebra shown in
`FIGS. 1 and 2, partially cut aWay and in section, With the
`offset expandable structure shown in FIG. 11A deployed by
`transpedicular access and being in a substantially expanded
`condition, forming a cavity that is substantially centered
`With respect to the middle region of the vertebral body;
`FIG. 13 is a coronal vieW of the lumbar vertebra shoWn
`in FIGS. 1 and 2, partially cut aWay and in section, With the
`offset expandable structure shoWn in FIG. 11 deployed by
`postero-lateral access and being in a substantially expanded
`condition, forming a cavity that is substantially centered
`With respect to the middle region of the vertebral body;
`FIGS. 14A and 14B are side vieWs of other embodiments
`of improved expandable structures, each having an axis of
`expansion that is offset by a distance from the axis of the
`supporting catheter tube;
`FIG. 15 is a side vieW of a conventional expandable
`structure shoWn in FIG. 4, enlarged to shoW further details
`of its geometry When substantially expanded;
`FIG. 16 is a side vieW of an improved expandable
`structure, When in a substantially expanded condition, Which
`includes end regions having compound curvatures that
`reduce the end region length and thereby provide the capa
`bility of maximum bone compaction substantially along the
`entire length of the structure;
`FIG. 17 is a side vieW of an improved expandable
`structure, When in a substantially expanded condition, Which
`includes end regions having compound curvatures that
`invert the end regions about the terminal regions, Where the
`structure is bonded to the supporting catheter tube, to
`provide the capability of maximum bone compaction sub
`stantially along the entire length of the structure;
`FIG. 18 is a side section vieW of an improved expandable
`structure, When in a substantially expanded condition, Which
`includes end regions that have been tucked or folded about
`the terminal regions, Where the structure is bonded to the
`supporting catheter tube, to provide the capability of maxi
`mum bone compaction substantially along the entire length
`of the structure;
`FIG. 19 is a side section vieW of a tubular expandable
`structure having a distal end bonded to an inner catheter tube
`and a proximal end bonded to an outer catheter tube, the
`inner catheter tube being slidable Within the outer catheter
`tube;
`FIG. 20 is a side section vieW of the tubular expandable
`structure shoWn in FIG. 19, after sliding the inner catheter
`tube Within the outer catheter tube to invert the end regions
`of the structure about the distal and proximal bonds, to
`thereby provide the capability of maximum bone compac
`tion substantially along the entire length of the structure;
`FIG. 21 is a side section vieW of a tubular expandable
`structure having a distal end bonded to an inner catheter tube
`and a proximal end bonded to an outer catheter tube, the
`inner catheter tube and structure being made of a more
`compliant material than the outer catheter tube to provide
`proportional length and diameter expansion characteristics;
`FIG. 22 is an enlarged plan vieW of a branched blood
`vasculature region, in Which an occlusion exists;
`FIG. 23 is a further enlarged vieW of the branched blood
`vasculature region shoWn in FIG. 22, in Which an asymmet
`ric expandable structure of the type shoWn in FIG. 11 is
`deployed to open the occlusion;
`FIG. 24 is a plan vieW of a sterile kit to store a single use
`probe, Which carries an expandable structures as previously
`shown;
`
`10
`
`15
`
`25
`
`35
`
`45
`
`55
`
`65
`
`4
`FIG. 25 is an exploded perspective vieW of the sterile kit
`shoWn in FIG. 24;
`FIG. 26 is a side vieW, With parts broken aWay and in
`section, of an expandable structure having an enclosed
`stiffening member, to straighten the structure during passage
`through a guide sheath into an interior body region; and
`FIG. 27 is a side vieW of the expandable structure shoWn
`in FIG. 27, after deployment beyond the guide sheath and
`into the interior body region, in Which the stiffening member
`includes a distal region having a preformed bend, Which
`de?ects the structure relative to the axis of the guide sheath.
`The invention may be embodied in several forms Without
`departing from its spirit or essential characteristics. The
`scope of the invention is de?ned in the appended claims,
`rather than in the speci?c description preceding them. All
`embodiments that fall Within the meaning and range of
`equivalency of the claims are therefore intended to be
`embraced by the claims.
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`The preferred embodiment ?rst describes improved sys
`tems and methods that embody features of the invention in
`the context of treating bones. This is because the neW
`systems and methods are advantageous When used for this
`purpose.
`Another preferred embodiment describes the improved
`systems and methods in the context of relieving constric
`tions or blockages Within branched blood vessels. This is
`because the vasculature also presents an environment Well
`suited to receive the bene?ts of the invention.
`The tWo environments are described for the purpose of
`illustration. HoWever, it should be appreciated that the
`systems and methods as described are not limited to use in
`the treatment of bones or the vasculature. The systems and
`methods embodying the invention can be used virtually in
`any interior body region that presents an asymmetric
`geometry, or otherWise requires an access path that is not
`aligned With the natural axis of the region.
`I. Deployment in Bones
`The neW systems and methods Will be ?rst described in
`the context of the treatment of human vertebra. Of course,
`other human or animal bone types, e.g., long bones, can be
`treated in the same or equivalent fashion.
`FIG. 1 shoWs a lateral (side) vieW of a human lumbar
`vertebra 12. FIG. 2 shoWs a coronal (top) vieW of the
`vertebra. The vertebra 12 includes a vertebral body 26,
`Which extends on the anterior (i.e., front or chest) side of the
`vertebra 12. The vertebral body 26 is in the shape of an oval
`disk. The geometry of the vertebral body 26 is generally
`symmetric arranged about its natural mid-anterior-posterior
`axis 66, natural mid-lateral axis 67, and natural mid-top-to
`bottom axis 69. The axes 66, 67, and 69 intersect in the
`middle region or geometric center of the body 26, Which is
`designated MR in the draWings.
`As FIGS. 1 and 2 shoW, the vertebral body 26 includes an
`exterior formed from compact cortical bone 28. The cortical
`bone 28 encloses an interior volume 30 of reticulated
`cancellous, or spongy, bone 32 (also called medullary bone
`or trabecular bone).
`The spinal canal 36 (see FIG. 2), is located on the
`posterior (i.e., back) side of each vertebra 12. The spinal
`cord (not shoWn) passes through the spinal canal 36. The
`vertebral arch 40 surrounds the spinal canal 36. Left and
`right pedicles 42 of the vertebral arch 40 adjoin the vertebral
`
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`5
`body 26. The spinous process 44 extends from the posterior
`of the vertebral arch 40, as do the left and right transverse
`processes 46.
`US. Pat. Nos. 4,969,888 and 5,108,404 disclose appara
`tus and methods for the ?xation of fractures or other
`conditions of human and other animal bone systems, both
`osteoporotic and non-osteoporotic. The apparatus and meth
`ods employ an expandable structure to compress cancellous
`bone and provide an interior cavity. The cavity receives a
`?lling material, e.g., bone cement, Which hardens and pro
`vides reneWed interior structural support for cortical bone.
`The compaction of cancellous bone also exerts interior force
`upon cortical bone, making it possible to elevate or push
`broken and compressed bone back to or near its original
`prefracture, or other desired, condition.
`FIG. 3 shoWs a tool 48, Which includes a catheter tube 50
`having a proximal and a distal end, respectively 52 and 54.
`The catheter tube 50 includes a handle 51 to facilitate
`gripping and maneuvering the tube 50. The handle 51 is
`preferably made of a foam material secured about the
`catheter tube 50.
`The distal end 54 carries an expandable structure 56,
`Which FIG. 3 shoWs to be of conventional construction. The
`structure 56 is shoWn in FIG. 3 in a substantially collapsed
`geometry. The structure 56 conventionally comprises an
`elongated tube, formed, for example, by standard polymer
`extrusion and molding processes. The tubular structure 56 is
`bonded at its opposite ends 58 to the catheter tube 50, using,
`for example, an adhesive. When substantially collapsed, the
`structure 56 can be inserted into an interior body region.
`Tubular bodies of the type shoWn in FIG. 3 are made from
`polymer materials and are commonly deployed in veins and
`arteries, e.g., in angioplasty applications. FIG. 4 shoWs an
`enlarged vieW of the structure 56 When in a substantially
`expanded geometry. As FIG. 4 shoWs, the middle region 64
`of the tubular structure 56, When substantially expanded,
`assumes a generally cylindrical shape, Which is symmetric
`about the main axis 60 of the catheter tube 50. Expansion
`stretches the polymer material of the structure 56 near its
`bonded ends 58 to form generally conical end portions 62.
`The structure 56 can be inserted into bone in accordance
`With the teachings of the above described US. Pat. Nos.
`4,969,888 and 5,108,404. For a vertebral body 26, access
`into the interior volume 30 can be accomplished, for
`example, by drilling an access portal 43 through either
`pedicle 42. This is called a transpedicular approach, Which
`FIG. 5 shoWs in lateral vieW and FIG. 6 shoWs in coronal
`vieW. As FIG. 5 shoWs, the access portal 43 for a trans
`pedicular approach enters at the top of the vertebral body 26,
`Where the pedicle 42 is relatively thin, and extends at an
`angle doWnWard toWard the bottom of the vertebral body 26
`to enter the interior volume 30. As FIGS. 5 and 6 shoW, in
`a typical transpedicular approach, the access portal 43 aligns
`the catheter tube axis 60 obliquely With respect to all natural
`axes 66, 67, or 69 of the vertebral body 26.
`As the conventional structure 56 expands Within the
`interior volume 30 (as FIGS. 7 and 8 shoW, respectively, in
`lateral and coronal vieWs for the transpedicular approach),
`the structure 56 symmetrically expands about the catheter
`tube axis 60, compressing cancellous bone 32 to form a
`cavity 68. HoWever, since the catheter tube axis 60 is
`oriented obliquely relative to all natural axes 66, 67, or 69,
`the formed cavity is not centered With respect to the middle
`region MR. Instead, the cavity 68 is offset on one lateral side
`of the middle region MR (as FIG. 8 shoWs) and also extends
`from top to bottom at oblique angle through the middle
`region MR (as FIG. 7 shoWs).
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`55
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`60
`
`65
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`6
`Due to these asymmetries, the cavity 68 Will not provide
`optimal support to the middle region MR When ?lled With
`bone cement. Since the bone cement volume is not centered
`about the middle region MR, the capability of the vertebral
`body 26 to Withstand loads is diminished. The asymmetric
`compaction of cancellous bone 32 in the interior volume 30
`may also exert unequal or nonuniform interior forces upon
`cortical bone 32, making it dif?cult to elevate or push broken
`and compressed bone.
`As FIG. 9 shoWs, access to the interior volume 30 of the
`vertebral body 26 also can be achieved by drilling an access
`portal 45 through a side of the vertebral body 26, Which is
`called a postero-lateral approach. The portal 45 for the
`postero-lateral approach enters at a posterior side of the
`body 26 and extends at angle forWardly toWard the anterior
`of the body 26.
`As FIG. 9 shoWs, the orientation of the portal 45 in a
`typical postero-lateral approach does not permit parallel or
`perpendicular alignment of the catheter tube axis 60 With
`either the mid-lateral axis 67 or the mid-anterior-posterior
`axis 66 of the vertebral body 26. As a result, symmetric
`expansion of the conventional structure 56 about the catheter
`tube axis 60 forms an off-centered cavity 68‘, Which extends
`obliquely across the middle region MR of the body 26, as
`FIG. 10 vieW shoWs. As With the cavity 68 formed by the
`structure 56 using transpedicular access, the off-centered
`cavity 68‘ formed by the structure 56 using postero-lateral
`access also fails to provide optimal support to the middle
`region MR When ?lled With bone cement.
`A. Optimal Orientation for Cancellous Bone Compaction
`FIG. 11A shoWs an improved bone treating tool 14, Which
`includes a catheter tube 16 carrying at its distal end 18 an
`expandable structure 20. The catheter tube 16 can, at its
`proximal end, be con?gured like the tube 50 shoWn in FIG.
`3, With a handle 51 made of, e.g., a foam material.
`FIG. 11A shoWs the structure 20 in a substantially
`expanded condition, in Which the structure comprises a
`cylinder 21 With generally conical portions 34, each having
`a top 25 and a base 27. The tops 25 of conical portions 34
`are secured about the catheter tube 16 and, in this respect,
`are generally aligned With the catheter tube axis 24.
`HoWever, unlike the expandable structure 56 shoWn in FIG.
`4, the main axis 22 of the cylinder 21 and the axis 24 of the
`catheter tube 16 are not aligned. Instead, the cylinder axis 22
`is offset at an angle A from the catheter tube axis 24. As a
`result, the structure 20, When substantially expanded (as
`FIG. 11A shoWs), is not symmetric With respect to the
`catheter tube axis 24.
`In FIG. 11A, the bases 27 of the conical portions 34
`extend generally perpendicularly to the cylinder axis 22. In
`this orientation, the tops 25 and the bases 27 are not parallel
`to each other. Other orientations are possible. For example,
`in FIG. 11B, the bases 27 of the conical portions 34 extend
`generally perpendicularly to the catheter tube axis 24. In this
`orientation, the tops 25 and the bases 27 are generally
`parallel to each other.
`FIG. 12 shoWs in lateral vieW, the offset structure 20
`shoWn in FIG. 11A deployed by a transpedicular approach in
`the interior volume 30 of a vertebral body 26. As before
`shoWn in FIGS. 7 and 8, the transpedicular approach in FIG.
`12 does not align the catheter tube axis 24 With any of the
`natural axes 66, 67, and 69 of the body 26. HoWever, as FIG.
`12 shoWs, the expansion of the offset cylinder 21 of the
`structure 20 about its axis 22 is not symmetric With respect
`to the catheter tube axis 24. Instead, expansion of the offset
`structure 20 is generally aligned With the natural axes 66 and
`
`STRYKER EXHIBIT 1001, pg. 17
`
`ORTHOPHOENIX EXHIBIT 2009
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`IPR2014-01535 Page 17 of 23
`
`

`
`US 6,623,505 B2
`
`15
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`35
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`45
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`55
`
`65
`
`7
`69 of the vertebral body 26. As FIG. 12 shows, a single offset
`structure 20 introduced by transpedicular access, forms a
`cavity 38 that, While still laterally offset to one side of the
`middle region MR (as shoWn in FIG. 8), is nevertheless
`symmetric in a top-to-bottom respect With the middle region
`MR. A matching, adjacent cavity can be formed by trans
`pedicular deployment of a second offset structure 20 on the
`opposite lateral side of the vertebral body 26. The composite
`cavity, formed by the tWo offset bodies 20, introduced
`simultaneously or in succession by dual transpedicular
`access, is substantially centered in all respects about the
`middle region MR.
`FIG. 13 shoWs the offset expandable structure 20
`deployed by a postero-lateral approach in the interior vol
`ume 30 of a vertebral body 26. As before shoWn in FIG. 9,
`the postero-lateral approach in FIG. 13 does not align the
`catheter tube axis 24 With the natural axes 66 and 67 of the
`body 26. The expansion of the offset structure 20, Which is
`asymmetric about the catheter tube axis 24, is nevertheless
`generally symmetric With respect to all natural axes 66, 67,
`and 69 of the vertebral body 26. Asingle offset structure 20,
`deployed by postero-lateral access, forms a cavity 38‘, Which
`is substantially centered about the middle region MR.
`A cavity centered With respect to the middle region MR
`provides support uniformly across the middle region MR
`25
`When ?lled With bone cement. The capability of the vertebral
`body 26 to Withstand loads is thereby enhanced. The sym
`metric compaction of cancellous bone 32 in the interior
`volume 30 that a centered cavity provides also exerts more
`equal and uniform interior forces upon cortical bone 32, to
`elevate or push broken and compressed bone.
`FIGS. 14A and 14B shoW an expandable structure 200
`having an offset, asymmetric geometry different than the
`geometry of the offset expandable structure 20 shoWn in
`FIGS. 11A and 11B. In FIGS. 11A and 11B, the offset angle
`AbetWeen the cylinder axis 22 and the catheter tube axis 24
`is an acute angle. As a result, the axis 22 of the structure 20
`is offset in a nonparallel dimension or plane relative to the
`catheter tube axis 24. In FIGS. 14A and 14B, the offset angle
`A betWeen the cylinder axis 220 and the catheter tube axis
`240 is Zero, as the axis 220 of the cylinder 210 is offset at
`a distance from and in a generally parallel dimension or
`plane relative to the catheter tube axis 240. The catheter tube
`160 can, at its proximal end, be con?gured like the tube 50
`shoWn in FIG. 3, With a handle 51 made of, e.g., a foam
`material.
`As in FIGS. 11A and 11B, the tops 250 of conical portions
`340 are secured about the catheter tube 160 and, in this
`respect, are generally aligned With the catheter tube axis
`240. In FIGS. 14A and 14B, the orientation of the bases 270
`of the conical portions 340 differ. In FIG. 14A, the bases 270
`of the conical portions 340 extend generally perpendicularly
`to the catheter tube axis 240, and are therefore generally
`parallel to the tops 250 (comparable to the orientation shoWn
`in FIG. 11B). In FIG. 14B, the bases 270 of the conical
`portions 340 extend at an angle B to the catheter tube axis
`240. In this orientation, the tops 250 and the bases 270 are
`not parallel to each other.
`FIGS. 11A and 11B and 14A and 14B shoW that it is
`possible, by adjustment of the offset angle A, as Well as
`adjustment of the orientation of the conical end bases, to
`achieve virtually any desired offset geometry, and thereby
`tailor the orientation of the expandable structure to the
`particular geometry of the point of use.
`B. MaximiZing Cancellous Bone Compaction
`Referring back to FIG. 4, When the conventional tubular
`structure 56 shoWn in FIG. 4 is substantially expanded,
`
`8
`material of the structure is stretched into conical sections 62
`near the ends 58, Which are bonded to the catheter tube 50.
`FIG. 15 shoWs the geometry of expanded tubular structure
`56 in greater detail. The conical portions 62 extend at a cone
`angle 0t from the bonded ends 58. The expanded structure 56
`therefore presents the generally cylindrical middle region
`64, Where the maximum diameter of the structure 56
`(BODYDIA) exists, and the conical portions 62, Which
`comprise regions of diameter that decreases With distance
`from the middle region 64 until reaching the diameter of the
`catheter tube (TUBEDIA)
`Due to the geometry shoWn in FIG. 15, maximum can
`cellous bone compaction does not occur along the entire
`length (L2) of the conventional structure 56, as measured
`betWeen the bonded ends 58. Instead, maximum cancellous
`bone compaction occurs only along the effective length (L1)
`of the cylindrical middle region 64 of the structure 56, Where
`the structure 56 presents its maximum diameter BODYDIA.
`Cancellous bone compaction diminishes along the length of
`the conical portions 62, Where the structure’s diameter
`progressively diminishes. At the bonded ends